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Jun 14, 2013

What Did We Learn from Myriad?

A lawyer’s perspective on the Supreme Court decision that’s shaking the biotech industry.

In a highly anticipated ruling, the United States Supreme Court has determined that an isolated DNA segment is a product of nature and therefore not eligible for patent protection. However, the Court ruled that complementary DNA (cDNA) is patent eligible because it is not naturally occurring (Association for Molecular Pathology et al. v. Myriad Genetics, Inc., 569 U.S. ____ (2013)).

The Myriad decision follows a long line of Supreme Court precedent and is entirely consistent with cases such as Funk Brothers v. Kalo, 333 U.S. 127 (1948), in which the novel combination of unmodified bacteria was held not to be patentable; and Diamond v. Chakrabarty, 447 U.S. 303 (1980) in which a genetically modified organism was held to be patentable. The Court has consistently held that compositions of matter found in nature and unaltered in any way are not eligible for patent protection. (See 333 U.S. 127, 132.) As the BRCA claims at issue in the Myriad case were directed to compositions (the DNA) that exist in nature, it should be no surprise that the Court held those compositions to be ineligible for patent protection.

Unfortunately, the Court’s decision has left some commentators with the impression that the “patent system is under attack” (quoting Q. Todd Dickinson, executive director of the American Intellectual Property Law Association). From a scientific point of view, the discovery of a new gene requires a significant amount of labor, insight, and understanding of the genome. It is reasonable for scientists to want to be rewarded for that effort; and in theory there would be nothing wrong with conferring patent protection on the discovery of natural phenomena and compositions found in nature. However, the long-standing precedent of the Supreme Court goes in the other direction. Thus, while the Myriad decision may be troubling to scientists who put in the extraordinary effort to discover new genes and new mutations, it is consistent with the law as it existed prior to the decision. Far from an attack on the patent system, the Myriad decision provides continuity and consistency to our body of caselaw.

Another misconception around the Myriad case is that it will stifle innovation. In fact, it is likely that many products, including diagnostic assays and tools, that may not have been launched previously for fear of patent infringement will now be made available. Thus, the Myriad decision opens up the possibility for new innovations in how we use and analyze genetic data for diagnostic and therapeutic purposes. That, in turn, may lead to better and more diverse products and lower prices as a result of market diversification.

Finally, and most importantly, the Myriad decision is a reminder of the importance of claiming commercial barriers to entry and not “technology” (which Myriad did well in many of the claims that were not challenged in court). The job of the patent lawyer is to find innovation and apply it in the commercial context in order to create barriers to entry. Claims to specific gene or protein sequences, even if they were patent-eligible, are not barriers to entry due to the many ways of designing around such claims. Rather than claiming the technical output, patent lawyers must step back and look for the true applications of innovation in the commercial marketplace. The purpose of a patent application is not to showcase technology; a scientific publication is much better in that regard. A patent application is a business document that, when done properly, describes a problem and its solution and, most importantly, claims an innovation in a manner that creates an appropriate and commercially valuable barrier to entry. After all, the only purpose of a patent is to prevent others from making, using, selling, offering for sale, or importing that which is claimed. To the extent we focus on simply claiming technology, we miss significant opportunities to create appropriate barriers. Viewed through one facet of the prism, the Myriad case is simply a restatement of long-standing precedent. However, if we dig a little deeper, it is a reminder of the real purpose and importance of patent claims.

Readers' Comments

Posted 06/17/2013 by Gordon Robinson

Patents are also about discovering new things and protecting the associated inventions long enough to learn their utility and commercially profit from them. The pre-existing "product of nature" argument used by SCOTUS to justify their decision on human gene patentability contradicts fundamental precedents set by many composition of matter patents for other natural compounds such as taxol, vincristine, etc, where the isolation of single molecules from complex biological mixes, structural identification and potential utility descriptions are deemed sufficient for patentability. Likewise, how will this ruling effect the patentability of biomarkers and novel, useful (but perhaps natural) genetic variants that can serve as the basis for new agricultural products? The bykill effects fromf this very political decision will ripple into many other realms. Non-scientists need to be reminded that patents do not confer "ownership" of anything, just a limited-term "lease" on its use.

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